BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ELEMENTS

    MDR report key: 2732612 · Received August 31, 2012

    Report

    Report Number
    MW5026793
    Event Type
    Malfunction
    Date Received
    August 31, 2012
    Date of Event
    August 24, 2012
    Report Date
    August 31, 2012
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAMINA SPREADER INSTRUMENT BROKE DURING USE IN LUMBAR FUSION SURGERY. OPERATING ROOM WAS SEARCHED BUT ONE PIECE OF INSTRUMENT WAS STILL UNACCOUNTED FOR. X-RAY DID NOT IDENTIFY ANY FOREIGN BODY IN PT. INFO WAS RELAYED TO VENDOR AND INSTRUMENT WAS TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL ELEMENTS LAMINA SPREADER NKB SPINAL ELEMENTS 10100-000 060169

    Patients

    Seq Age Sex Outcome Treatment
    1